17OHP-C Dosing Among Obese Pregnant Women

• Status: Unknown status
• Trial end date: 2020-08-23
• Target enrollment: 0
• Participant gender: Female

Summary

Emergency data suggest 17OHP-C may be less efficacious in obese women. Since obesity is associated with lower levels of plasma 17OHP-C, the investigator hypothesize that higher doses of 17OHP-C may help to prevent spontaneous PTB among obese women. The study aims to compare the pharmacokinetics of 17 OHP-C in obese compared with non-obese women.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Florida
• Collaborator: Washington University School of Medicine
• Treatments: 11-hydroxyprogesterone; 17 alpha-Hydroxyprogesterone Caproate; 17-alpha-hydroxy-progesterone caproate

Criteria

Inclusion Criteria:

• - Pregnant women, with a singleton gestation

• Ages 18 - 55

• Able to read and write in English and / or Spanish

• History of spontaneous PTB

• Obesity (≥ 30 kg / m2 ) vs non-obese groups (18 - 29.9 kg / m2 ) defined by first documented body mass index at an office visit

• Gestational age between 12 weeks, 0 days and 24 weeks, 6 days of gestation

• An ultrasound before 24 + 6 weeks gestation to confirm dating and to rule out major fetal anomalies

• Willing to have weekly injections at the physician's office

• The newborn will be enrolled on the mothers consent for chart review only

https://register.clinicaltrials.gov/prs/html/definitions.html?popup=true#Eligibility

Exclusion Criteria:

• - Multifetal gestation

• Known fetal anomaly

• Current progesterone treatment

• Known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions

• Current or history of thrombosis or thromboembolic disorder

• Current anticoagulation

• Undiagnosed abnormal vaginal bleeding unrelated to pregnancy

• Cholestatic jaundice of pregnancy

• Liver tumors, benign or malignant, or active liver disease

• uncontrolled hypertension (controlled hypertension is eligible)

• A seizure disorder

• Current or planned cervical cerclage

• Plan to deliver elsewhere